Clinical Statistical Programmer III Senior

Department: Clinical Data Sciences
Reports to: Senior Director, Statistical Programming
Title: Senior Statistical programming Contractor

Background Requirements and Qualifications:
* Minimum of 10+ years of hands-on statistical programming experience in the pharmaceutical, biotech, or CRO industry.
* Advanced knowledge of GCP/ICH guidelines and FDA regulatory requirements; prior experience with NDA/MAA/BLA submissions is preferred.
* Strong expertise in SAS programming and macro development; experience with R or Python is a plus.
* In-depth knowledge of CDISC standards including SDTM, ADaM, Define.xml, and submission-ready datasets.
* Demonstrated ability to manage multiple projects and shifting priorities in a fast-paced environment.
* Excellent written and verbal communication skills.

Skills:
* Expert level proficiency in SAS programming and experience in CDISC SDTM/ADaM and submission standards
* Expert level ability to write efficient, reusable macros and provide innovative programming solutions.
* Strong project management skills with the ability to prioritize tasks and meet tight deadlines while maintaining high quality.
* Familiarity with programming in R or Python for statistical analysis or automation is highly desirable.
* Experience supporting regulatory submissions and publication requests.

Position Overview: Basic Functions & Responsibilities
Responsible for providing expert-level, hands-on support across all internal statistical programming needs for clinical and device studies, regulatory submissions, and exploratory analyses, while also contributing to innovation and quality across the department.

Other Primary Activities:
* Provide expert-level hands-on support for all internal statistical programming needs for clinical, device studies including but not limited to CSR, ISS and ISE summaries and exploratory data analyses
* Perform rigorous quality control (QC) of programming deliverables to ensure accuracy and compliance with regulatory standards.
* Collaborate closely with biostatistics, data management, and cross-functional teams to support ongoing clinical trials, FDA submissions, publications, and other business needs.
* Develop, validate, and maintain departmental standard macros and template programs.
* Write and validate SAS programs to generate SDTM, ADaM datasets, and TLFs (Tables, Listings, and Figures).
* Write, review, and approve data specifications for SDTM and ADaM datasets.
* Contribute to the development and implementation of innovative programming strategies and tools.
* Ensure adherence to departmental SOPs, guidelines, and regulatory requirements.